Huntington's DiseaseNCT01735981

The Effect of Video Game Exercise on Dynamic Balance and Gait in Individuals With Huntington's Disease

A study testing Video game exercise using Dance Dance Revolution and hand-held video game in people with Huntington's Disease, run by Anne Kloos at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise modality to improve gait and balance in individuals with Huntington's disease. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Huntington's Disease
What is being tested?: Video game exercise using Dance Dance Revolution and hand-held video game
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adults 18 - 79 with a diagnosis of Huntington's disease

Who cannot join

cannot walk 10 feet without assistance, any other neurologic condition

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Atwell Hall
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: The Effect of Video Game Biofeedback Modulated Exercise (ViBE)on Dynamic Balance and Gait in Individuals With Huntington's Disease

To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise modality to improve gait and balance in individuals with Huntington's disease.

Read the detailed description

The primary purpose of this study was to determine the effectiveness of a therapist-guided Video-game Biofeedback Modulated Exercise (ViBE) program administered via Dance Dance Revolution to improve dynamic balance, gait and mobility in individuals with Huntington's Disease. Secondary aims were to explore whether the ViBE intervention would improve quality of life, fall risk, and neuropsychological functions. The investigators hypothesized that the video-game program would lead to greater improvements in walking, dynamic balance, quality of life, fall risk, and neuropsychological function than a control handheld video game program. Since motivation is essential to the long-term maintenance of an exercise program the investigators were also interested in finding out how successful people with Huntington's Disease were at playing Dance Dance Revolution, what their perceptions were of playing the game, and whether they thought that it was beneficial

Conditions: Huntington's Disease
Being tested: Video game exercise using Dance Dance Revolution, hand-held video game
Keywords: Huntington's Disease, gait, exercise, balance, video game
Medical subject headings: Huntington Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Video game exercise using Dance Dance RevolutionOther
Also called exercise, video-game based exercise
use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance
hand-held video gameOther
hand-held video games

Study groups in NCT01735981
Study group	Role	What they receive
video game exercise	Experimental	Video game exercise using Dance Dance Revolution Receives: Other: Video game exercise using Dance Dance Revolution; Other: hand-held video game
control	Other	hand-held video game control Receives: Other: Video game exercise using Dance Dance Revolution; Other: hand-held video game

What is being measured

The primary outcome is the main question the study is designed to answer.

Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: forward velocity.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: forward stride length.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: forward swing percent.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: forward double support percent.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: forward heel to heel base of support.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: backwards velocity.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: backwards stride length.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: backwards swing percent.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: backwards double support percent.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: backwards heel to heel base of support.
Measured: 6 weeks
Gait Parameters
utilized GAITRite to obtain spatiotemporal measures of gait: obstacle velocity.
Measured: 6 weeks

Secondary outcomes (4)

Tinetti Mobility Test
Observation of gait and balance with quantifiable 16-item assessment with an ordinal scale of 0-2 for up to a total score of 32, with higher scores indicating better performance. It is reliable and predicts falls among those with Parkinson's disease and Huntington's disease.
Measured: 6 weeks
Four Square Step Test
Examines ability to step over an object in multiple directions and is timed. Participants are instructed to step over a cane into each square in a specific order. Faster times indicate better balance. It has been shown to predict falls in the elderly.
Measured: 6 weeks
Activities-Specific Balance Confidence Scale
Individuals rate their balance confidence from 1-100 on 16 tasks and total score is the mean; higher scores indicate greater confidence and lower fall risk. The Activities-Specific Balance Confidence Scale is reliable and valid in elderly and neurological populations.
Measured: 6 weeks
World Health Organization Quality of Life
This questionnaire is a measure of quality of life addressing 4 domains including physical, psychological, social, and environment health. Responses on 26 items are on a five-point scale (from 1 = very dissatisfied to 5 = very satisfied) and each item is added to achieve a total score for each domain. The mean score for each domain is calculated then multiplied by 4 to get the domain score which are then transformed to a scaled score of 0-100 comparable to the original WHOQOL-100 therefore a total score between 0-400 with high scores indicating better quality of life. The WHOQOLBref has good reliability and validity.
Measured: post intervention and post hand-held game, each lasts 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jun 2012

First posted28 Nov 2012 (estimated)
Study startJun 2008
Primary completionNov 2010
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Model description: Participants completed one arm of the study and then crossed over into the other arm of the study
Masking: Single blind
Who is masked: Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01735981
Sponsor's protocol ID: 2008H0109
Status last verified: Jul 2021
First submitted: 7 Nov 2012
Last updated: 9 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Huntington's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Video Game Biofeedback Modulated Exercise (ViBE)on Dynamic Balance and Gait in Individuals With Huntington's Disease
ClinicalTrials.gov ID: NCT01735981
Acronym / sponsor ID: 2008H0109
Conditions: Huntington's Disease
Keywords: Huntington's Disease, gait, exercise, balance, video game
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Anne KloosUniversity, hospital or other
Study start: Jun 2008
Primary completion: Nov 2010 (actual)
Study completion: Jun 2012 (actual)
First posted: 28 Nov 2012 (estimated)
Results: Posted 9 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise modality to improve gait and balance in individuals with Huntington's disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2
Model description: Participants completed one arm of the study and then crossed over into the other arm of the study

Arm	Type	Receives
video game exercise	Experimental	Other: Video game exercise using Dance Dance Revolution, Other: hand-held video gameVideo game exercise using Dance Dance Revolution
control	Other	Other: Video game exercise using Dance Dance Revolution, Other: hand-held video gamehand-held video game control

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

adults 18 - 79 with a diagnosis of Huntington's disease

Key exclusion criteria (1 listed)

cannot walk 10 feet without assistance, any other neurologic condition

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Video game exercise using Dance Dance RevolutionAlso: exercise, video-game based exerciseuse of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance	Other	control, video game exercise
hand-held video gamehand-held video games	Other	control, video game exercise

Primary outcome

Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: forward velocity.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: forward stride length.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: forward swing percent.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: forward double support percent.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: forward heel to heel base of support.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: backwards velocity.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: backwards stride length.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: backwards swing percent.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: backwards double support percent.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: backwards heel to heel base of support.
Gait Parameters
Time frame: 6 weeks
utilized GAITRite to obtain spatiotemporal measures of gait: obstacle velocity.

4 secondary outcomes

Tinetti Mobility Test
Time frame: 6 weeks
Four Square Step Test
Time frame: 6 weeks
Activities-Specific Balance Confidence Scale
Time frame: 6 weeks
World Health Organization Quality of Life
Time frame: post intervention and post hand-held game, each lasts 6 weeks

Results and safety

Results posted to the registry on 9 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dance Dance Revolution Exercise, Then Hand Held Video Game (Control)	13	11
Hand Held Video Game (Control), Then Dance Dance Revolution Exercise	11	8

Primary outcome: Gait Parameters

Time frame: 6 weeks. Mean (Standard Deviation). Unit: meters per second

Measure	Dance Dance Revolution Exercise n = 17	Hand Held Video Game (Control) n = 17
Value	1.289 (0.47)	1.292 (0.47)

Population analysed: GAITRite outcome data was eliminated for one participant who consistently exhibited an abnormal gait during testing sessions on the walkway that did not reflect his usual walking pattern. One participant could not walk backward. Thus, 17 participants were included in the GAITRite analysis (n = 16 for backward condition).

Primary outcome: Gait Parameters

Time frame: 6 weeks. Mean (Standard Deviation). Unit: cm

Measure	Dance Dance Revolution Exercise n = 17	Hand Held Video Game (Control) n = 17
Value	123.35 (35.23)	123.11 (35.9)

Primary outcome: Gait Parameters

Time frame: 6 weeks. Mean (Standard Deviation). Unit: percentage of gait cycle spent in swing

Measure	Dance Dance Revolution Exercise n = 17	Hand Held Video Game (Control) n = 17
Value	36.82 (3.64)	36.01 (4.33)

Primary outcome: Gait Parameters

Time frame: 6 weeks. Mean (Standard Deviation). Unit: percent of gait cycle in double support

Measure	Dance Dance Revolution Exercise n = 17	Hand Held Video Game (Control) n = 17
Value	25.83 (7.36)	28.34 (8)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Course of the time from when the participant was enrolled in the study (8-12 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dance Dance Revolution Exercise	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Hand Held Video Game (Control)	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deb Kegelmeyer, DPT, MS principal investigator

Ohio State University

Anne Kloos, PT, PhD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Video game exercise using Dance Dance Revolution and hand-held video game in people with Huntington's Disease, run by Anne Kloos at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Parameters (time frame: 6 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01735981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.